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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name suture, surgical, absorbable, polydioxanone
510(k) Number K120284
Models 52025, 52026/52028, 52027/52029, 52030/52031, 52032/52033
Device Name DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
Original Applicant
COLOPLAST A/S
1601 west river road north
minneapolis,  MN  55411
Original Contact janell colley
Regulation Number878.4840
Classification Product Code
NEW  
Subsequent Product Code
GAM  
Date Received01/31/2012
Decision Date 05/23/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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